Sutures are used to sew tissue together, and thereby close tissue openings, cuts or incisions during or after any of a very wide variety of medical procedures. Additionally sutures may be utilized to correct patent foramen ovales (PFO) which are openings between the two atria of the heart. Typically, the surgeon manually ties together a suture pair to close the opening. A variety of automatic suture tying systems and suture securing mechanisms have been developed.
Manually tying sutures together to secure tissue can be very difficult and challenging. For example, manual knot tying requires considerable dexterity in the context of a medical procedure where the surgeon's hands are gloved or when the suturing is being performed in a part of a patient's anatomy that is particularly difficult to access. Also, in minimally invasive surgical procedures or in the case of closure of a puncture in a femoral artery after a catheterization procedure, the space adjacent the wound or tissue opening to be sutured is limited by other parts of the patient's anatomy and in many instances the opening to be closed cannot be visualized, therefore the knot must be formed blindly.
Also, manual knot tying can be time consuming as well as difficult in instances where the tying process cannot be visualized. Knot tying is further complicated by the fact that surgical sutures generally have low friction surfaces. Therefore, it is typically necessary for a surgeon to include many loops or “throws” when tying a knot. Multiple throws are often required even if an automatic knot tying device is used such as that disclosed in U.S. Pat. No. 6,171,317 the entirety of which is hereby incorporated by reference. Unfortunately, as the number of loops or “throws” incorporated into the knot increases, the knot becomes increasingly large and bulky. Manually tied knots also can become “locked” prior to reaching the intended amount of tension to be applied to the tissue. If the knot becomes “locked” prior to final deployment, the surgeon may be required to remove the suture and place a new suture if possible or resort to other closure methods such as compression if the suture was being utilized to close an opening in a vessel.
Moreover, the surgeon typically needs to handle suture strands having adequate length prior to commencing manual knot tying. Thus, manual knot tying requires considerable space both in which to view, and to perform, the actual knot tying. Therefore, knot tying is particularly difficult in areas of limited available space or access, for example, at the back of the patient's heart during a coronary artery bypass graft (CABG) operation or in a tissue tract resulting from a percutaneous transluminal catheterization procedure.
In addition to those problems described above, many of the sutures utilized for surgical procedures can only be manipulated to a certain degree before failure. For example, when tightening a knot, the suture is placed in tension by the surgeon, too much tension applied to the suture may cause the suture to break. Alternatively, too much tension applied to the suture may cause the suture to be torn from the tissue further complicating closure by creating a larger wound or opening in the tissue which then must be addressed.
Many knot replacement technologies for use with sutures have been proposed over the years, one example of a knot replacement technology is a deformable clip. Wherein the suture ends are disposed through a deformable member which is then deformed thereby trapping the suture therein. A shortcoming of this design is that the deformable member must be made to be sufficiently deformable but yet have enough strength to retain the suture therein. Further still, there is the possibility of the suture slipping from the deformed clip if the clip was not deformed sufficiently. Lastly, many of these deformable clips are constructed of non-absorbable materials and therefore remain implanted within the patient after use, which may lead to other complications such as infection or irritation of the surrounding tissue.
Another example of knot replacement technology is the use of a tortuous path, wherein the suture is disposed upon or within a device that contains a tortuous path, wherein friction between the suture and the device is utilized to retain the suture. A potential shortcoming of such devices is that since the suture is not physically retained within the device there is the potential for the suture to slip or loosen from the device. Additionally, many of these devices require a great amount of operator skill or time to dispose the suture therethrough, thereby adding to the complexity of a potentially already complex surgical procedure.
Therefore, for the above reasons, it would be desirable to provide improved devices, systems, and methods for securing at least one length of suture that has been used to suture tissue together to close an opening formed in the tissue such as a vascular puncture. It would be particularly beneficial if these improved devices provided some or all of the benefits while overcoming one or more of the disadvantages discussed above.
It is an object of the present invention to provide methods and devices that may be utilized in place of forming a knot in a suture to effect a closure of the suture.
It is a further object of the present invention to provide a knot replacement device that reduces surgical time by eliminating the need to form a knot during a surgical procedure.
It is yet another object of the present invention to provide a knot replacement device with is biocompatible and absorbable, thereby reducing the amount of foreign material remaining implanted within a patient after a surgical procedure.
These and other objects of the present invention will be apparent from the following detailed description and the claims.